TY - JOUR
AU1 - Banja, John D.
AU2 - Dunlop, Boadie
AB - Duty to Disclose Enhancing Informed Consent in Clinical Trials and Exploring Resistances to Disclosing Adverse Clinical Trial Results John D. Banja, Emory University Boadie Dunlop, Emory University rollment of new or currently enrolled subjects (Office for IS AN OVERSIGHT BODY NECESSARY? Human Research Protections 2007). The impression one derives from the target article on “The But from a purely practical perspective, can we really Duty to Disclose Adverse Clinical Trials Results” is that share the Liao and colleagues (2009) assumption that the Liao and colleagues (2009) envision a research platform proposed oversight body would be able to review and de- consisting only of a team of investigators and a commer- cide upon the relevance of all adverse event data collected cial sponsor, and without any support or monitoring from from all preclinical (including animal) studies for all drugs an institutional review board. Given the presumed absence under investigation? The undertaking would be enormous, of adequate regulatory oversight, the authors worry that yet they further propose that the oversight body be given the self-interests of either investigators or research spon- certain enforcement powers, such as assuring that partici- sors can result in critical risk or adverse event information pants do 
TI - Enhancing Informed Consent in Clinical Trials and Exploring Resistances to Disclosing Adverse Clinical Trial Results
JF - American Journal of Bioethics
DO - 10.1080/15265160902948330
DA - 2009-08-03
UR - https://www.deepdyve.com/lp/taylor-francis/enhancing-informed-consent-in-clinical-trials-and-exploring-0SA6Smb4GR
SP - 39
EP - 41
VL - 9
IS - 8
DP - DeepDyve
ER -